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New Legislation & Guidance for Pharmacovigilance Reporting has been applied in the European Union (EU) since July 2012. To assist in its implementation with sponsors, applicants and license holders, a series of Guidance Documents were written, which would replace the current set of Volume 9A of the Rules Governing Medicinal Products in the EU. The legal framework for pharmacovigilance on Medicinal Products for Human Use has now been updated, through an amended EU Regulation (No 1235/2010) and Directive (2010/84/EC).

This webinar by expert speaker Robert Russell is focused on understanding the EU Pharmacovigilance Reporting System requirements now in effect across the European Union. The New Guidance document Modules on Good Pharmacovigilance Practices (GVP) have been updated. License holders with commercial medicinal products on the market are expected to have an EU-compliant PV System and PV Manual ready for inspection by any Healthcare Authority or the EMA.

These inspections have already been in progress and can happen unannounced. Join this session to know the regulatory and guidance updates as well as thoughts on how member states having competent authorities have worked towards implementation. These regulatory changes are also going to impact the EU Clinical Trial Regulations as well as the sponsor’s expectations when it comes to protecting public and patient health – before, after and during clinical studies.

This session will provide you a thorough knowledge of all the updated frameworks surrounding Good Pharmacovigilance Practices (GVP), the EU regulation updates, PV guidance models and Directives that have already been published and launched. The webinar is specifically designed to simplify understanding of new requirements and equip you with latest information on what is being believed by the European Commission when it comes to improvement across the region.

Session Highlights:

Pharmacovigilance System

Pharmacovigilance Manual

Reporting and Management of Adverse Reactions

Periodic Safety Update Reports

Post Authorization Safety Studies

Changes to Definitions

The Pharmacovigilance Risk Assessment Committee

Overview of EU Regulatory structure

EU Pharmacovigilance: What GVP System must be in-place?

New definitions for the updated Directive and Regulation

Organization of PV Modules & Summary of Contents

Updates from the EU Pharmacovigilance Legislation

How the new legislation will better protect patient safety

How the new legislation will affect Marketing Authorization Holders

How the new legislation will affect Sponsors of Clinical Studies

Adverse Drug Reaction Reporting –

Periodic Safety Update Reports

Post-Authorization Safety Studies

Eudravigilance Database

Changes to labeling

The Pharmacovigilance Risk Assessment Committee

Implementation across the Member States

Who Should Attend

This Webinar will provide invaluable assistance to all personnel in the Pharmaceutical, Biotechnology and CRO industry involved in maintaining Compliance across the responsibilities in European Pharmacovigilance such as:

Senior Management

Project Managers

Clinical Trial Heads

PV Reporting

Medical Writers

Project Managers

CRAs and CRCs

QA / Compliance personnel

Investigators

Clinical Research Scientists

QA / QC Auditors and Staff

Consultants

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

Robert Russell, holds a B.S. and M.S.in Chemistry. Prior to founding RJR Consulting, Inc., a Global Regulatory Consulting firm in 2001, Mr. Russell spent 28 years in the Pharmaceutical and Medical Device Industry with two Fortune 150 firms working in CMC, Global Business Development and Regulatory Affairs.

Today, Robert assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations...
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